Pregnancy And Infancy Reduced Stress study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 560

Inclusion Criteria

Study 1:
In order to be eligible to participate in this study, a subject must meet all of the following criteria: The pregnant women should be >18 years of age, and <22 weeks pregnant. They should have at least moderate levels of prenatal stress, determined by a score of 22 or higher on the PSS, or a score of 21 or higher on the PRAQ-R.;Study 2:
In order to be eligible to participate in this study, a subject must meet all of the following criteria: For pregnant women see *Study 1* above. The non-pregnant women need to have comparable ages, relevant for matching purposes, and should have at least moderate levels of stress, determined by a score of 22 or higher on the PSS.

Exclusion Criteria

Study 1
A potential subject (pregnant woman) who meets any of the following criteria will be excluded from participation in this study: (1) chronic medical conditions such as Diabetes, (2) use of medication which is known to affect cardiovascular stress reactivity measures (e.g., * blockers), (3) substance abuse, (4) insufficient command of the Dutch language required to fill out questionnaires, (5) a score of 16 or higher on the depression scale of the HADS (cut-off score for severe depression), and (6) presence of a history of other severe mental disorders, such as Bipolar disorder or Schizophrenia.;If the partner of the pregnant woman meets any of the following criteria, the couple will be excluded from participation in this study: (1) presence of a history of other severe mental disorders, such as Bipolar disorder or Schizophrenia, (2) substance abuse, (3) insufficient command of the Dutch language required to fill out questionnaires.;Study 2
See exclusion criteria women of study 1.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Numbering corresponds to numbering Primary Objective<br /><br>(a) Perceived stress and anxiety (pregnant women and their partners) assessed<br /><br>by means of self-report on validated questionnaires; stress physiology of<br /><br>parameters of the autonomic nervous system (e.g. heart rate, heart rate<br /><br>variability, pre-ejection period, respiratory sinus arrhythmia, skin<br /><br>conductance responses) as measured by basal functioning and by responses to a<br /><br>standardized stress task;<br /><br>(b) Medical complications during pregnancy; birth outcomes for the mother and<br /><br>child with regard to: gestational age, birth weight, APGAR scores (1-5<br /><br>minutes), method of delivery, complications;<br /><br>(c) Infant behaviour and development: sleep patterns, feeding patterns, crying,<br /><br>infant temperament, motor and mental development.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Numbering corresponds to numbering Secundary Objectives<br /><br>(1) HRV-biofeedback parameters (related to changes in total blood volume).<br /><br>(2) Usability and validity of the DTI-2.<br /><br>(3) Diverted attention, using an emotional interference task. </p><br>